大手外資製薬メーカー　PV QC/Trainer

Company Overview
欧州系企業らしい穏やかな雰囲気が魅力の同社。グローバルにおける日本のプレゼンスが高く、良好な関係が築けているため、各部門でグローバルへの異動やShort-time assignmentの実績があります。
本ポジションもグローバルと距離が近く、部門長も外国籍の方となるため、英語に抵抗がない方を募集しております。チームメンバーも海外経験がおありの方が複数いらっしゃいます。
直属の上長となる方からも直接詳細をお伺いしておりますので、お気軽にお問い合わせください。

Job Description
• Promptly and accurately identify, interpret and extract adverse event and all relevant corresponding case information from a wide variety of source documents
• Enter the extracted information into the global database for serious and non-serious AE/ADR case reports
• Identify information such as product technical complaints in the source documents, which must be further processed by the local affiliate, and forward accordingly
• Adhere to internal data entry standards and specific timelines as prescribed by global regulations and SOPs
• Create and review comprehensive medical case narratives with no important gaps regarding the reported information received
• Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name)
• Perform accurate coding of incoming serious and non-serious adverse events and other case information using MedDRA terminology
• Perform assessment of cases regarding the global listed-ness
• Enter drug-event relationship in non-serious and serious expected ADR/AE case reports as per company policies
• Contribute to a continuous improvement of Pharmacovigilance (PV) system and processes
• Ensure medical plausibility, consistency and completeness of ADR case reports and appropriate case level status with regard to regulatory agency reporting
• Request follow-up information for the completion of case reports making use of specific product/event-related questionnaires when necessary. Consult medical experts within TA group for advice in clinical questions
• Perform Data Entry Quality Control review of cases entered and training of newcomers as required

Requirements
• Bachelors degree or above in life sciences
• Pharmacovigilance case processing and data entry experience of at least 1-2 years is required
• Experiences in data entry QC or training is preferred
• Should be willing and able to quickly develop in-depth understanding of database field structure, and processing rules
• Should have or quickly develop basic knowledge of ICH principles of SAE/AE reporting along with basic understanding of local and global regulatory rules and regulations and basic knowledge of safety policies and procedures in the major countries
• Should have or quickly develop good understanding of AE and drug coding conventions (MedDRA, WHO-DD)
• Basic knowledge of standard office software packages (Word, Excel)
• High sense of responsibility and accountability and special sense for diligence even for routine processes
• Proactive behavior and ability to keep timelines
• Well established interpersonal skills. Excellent oral and written communication skills are essential
• Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology
• Should possess well established decision-making and organizational skills, along with practiced training skills
• Most important competences are drives results and manages complexity
• Should possess or quickly develop the ability to establish cooperative working relationships with staff from different cultural and medical backgrounds
• Fluency in English (verbally and in writing / TOEIC 700+ desired) and Japanese
• Must be able to fluently communicate with colleagues from Pharmacovigilance data entry sites in other countries around the world

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